A Study to Evaluate the Accuracy, Usability, and Acceptance of a Blood-Based HIV Self-Test Performed by Observed Intended Users in Canada

Abstract

Introduction: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.